Label: SARNA- pramoxine hydrochloride lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-1587-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0145-0630
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 11, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days.
Caution -- Do not use in the eyes or nose. Not for prolonged use. Do not apply to large areas of the body. If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by a physician.
- Directions
- Other Information
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Inactive ingredients
benzyl alcohol, carbomer 940, cetyl alcohol, dimethicone, glyceryl stearate, isopropyl myristate, PEG-8 stearate, PEG-100 stearate, petrolatum, purified water, sodium hydroxide, stearic acid
Find more about Sarna!
Stiefel Laboratories, Inc.
Research Triangle Park, NC 27709
www.sarna-skincare.com
Made in Canada
A099718
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SARNA
pramoxine hydrochloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-1587(NDC:0145-0630) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYOXYL 8 STEARATE (UNII: 2P9L47VI5E) POLYOXYL 100 STEARATE (UNII: YD01N1999R) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-1587-0 222 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/28/2008 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel(54868-1587)
